The following data is part of a premarket notification filed by Pneu Pac, Ltd. with the FDA for Parapac 200 Medic, Model P200, & Parapac 200d Medic, Model P200d.
| Device ID | K020899 |
| 510k Number | K020899 |
| Device Name: | PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | PNEU PAC, LTD. SMITHS MEDICAL N7 W22025 JOHNSON ROAD Waukesha, WI 53186 -1856 |
| Contact | Donald Alexander |
| Correspondent | Donald Alexander PNEU PAC, LTD. SMITHS MEDICAL N7 W22025 JOHNSON ROAD Waukesha, WI 53186 -1856 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-20 |
| Decision Date | 2002-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019315072738 | K020899 | 000 |
| 10610586046063 | K020899 | 000 |
| 10610586046056 | K020899 | 000 |
| 10610586045530 | K020899 | 000 |
| 10610586045516 | K020899 | 000 |
| 10610586045509 | K020899 | 000 |
| 35019517159640 | K020899 | 000 |
| 35019517159602 | K020899 | 000 |
| 35019517159121 | K020899 | 000 |